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Healthy Skepticism Library item: 16905

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.


Publication type: news

Perrone M
Drugmakers, FDA move to curb painkiller abuse
Yahoo Finance 2009 Dec 4

Full text:

Pharmaceutical executives laid out plans Friday to prevent the misuse of prescription painkillers, under pressure from regulators trying to stop hundreds of fatal overdoses each year.

But Food and Drug Administration officials said industry’s proposals were short on specifics and that more work is needed before any measures are put in place.

Johnson & Johnson, King Pharmaceuticals and other drugmakers proposed using patient medication guides, letters to doctors and additional physician training to curb inappropriate use and prescribing of painkillers.

The FDA sent letters to 16 companies in February ordering them to design so-called risk management plans for their drugs. The drugmakers are presenting their joint proposal to the agency after several months of discussion.

The companies at Friday’s meeting produce 24 opioid drugs — including morphine, oxycodone and methadone — which are often abused for their euphoric effect.

The FDA has required risk management plans for individual drugs before, but never for an entire class of drugs.

Industry consultant Sidney Schnoll said the requirement is “unprecedented in the history of pharmaceutical medicine and in the history of the FDA.” Risk management plans can include: safety labeling, educational campaigns and even certification requirements for physicians.

Schnoll and others warned that mandatory certification standards could cause some physicians to stop prescribing the medications altogether, limiting access to patients.

“The bottom line here is that the ‘risk management plans’ should not impede important medication from reaching appropriate patients,” said Schnoll, a paid consultant for the companies with Pinney Associates.

In place of mandatory certification, the drug industry said the federal Drug Enforcement Administration could offer voluntary training to prescribers. However, executives acknowledged that congressional action would be needed to allow the DEA to provide such training. Currently, the agency’s mission is to enforce laws governing highly addictive medications.

FDA leaders expressed concern that a key component of the companies’ plan relies on congressional action.

“Congress can act very quickly sometimes and very slowly other times,” said Dr. John Jenkins, FDA’s director of new drugs. “And sometimes they don’t act at all.”

Other FDA officials said they wanted to hear more specifics from the drugmakers.

No matter what form they take, the final risk management plans won’t be in place anytime soon. FDA officials said they want to hold another public meeting in the spring to gather more input before finalizing the requirements.

The products targeted by the FDA, which come in both pill and patch forms, generally feature extended-release formulas designed to give long-lasting effects. But that potency carries serious risks when patients abuse them as stimulants.

The FDA has issued a number of warnings on prescription pain relievers in recent years but with little success. A federal survey conducted in 2007 found 5.2 million people in the U.S. reported using prescription pain drugs inappropriately.

Companies attending the meeting include makers of generic pills as well as brand-name products, like Johnson & Johnson’s Duragesic patch, King Pharmaceuticals’ extended-releases Avinza and Embeda pills, and Purdue Pharma’s extended-release OxyContin.

There are other problems with opioids besides deliberate abuse.

The FDA has documented many cases of physicians prescribing the potent painkillers for patients with migraine headaches, an unapproved use. The FDA said patients also sometimes chew extended-release pills that are designed to be swallowed, causing an overdose of the drug.


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